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Thursday, January 06, 2022 10:35:54 AM

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$OTLC Oncotelic Initiates Phase 1 Trial Evaluating CA4P in Combination with Pembrolizumab for Melanoma

AGOURA HILLS, Calif., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-ß therapeutics for oncology and virology, today announced that it has submitted a clinical study protocol to the United States Food and Drug Administration (“US FDA”) for the initiation of a Phase 1 Clinical Trial for CA4P, the Company’s Vascular Disrupting Agent, in combination with Anti-PD-1 (pembrolizumab) as a treatment for patients with Melanoma.

The Phase 1 Clinical Trial is designated as S101: Phase 1, Prospective, Multicenter, Open-Label, Single Arm Study of Safety and Initial Efficacy of CA4P in Combination with anti-PD1 (pembrolizumab) in Patients with Recurrent Metastatic Cutaneous or Uveal Melanoma.

CA4P has been evaluated in over 500 patients and treated in 17 clinical studies to date. These included multiple Phase 1 dose escalation studies, with dose cohorts up to 114 mg/m2, when used as monotherapy, 63 mg/m2 when used in combination with paclitaxel, and 63 mg/m2 when used in combination with bevacizumab. Based on the early Phase 1 studies, CA4P was further studied in larger Phase 2 studies including:

• Ovarian cancer - 60 mg/m2 CA4P in combination with 15 mg/kg bevacizumab (n=54) in combination with physician’s choice chemotherapy;

• Anaplastic thyroid cancer - 60 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=51);

• Platinum resistant ovarian cancer - 63 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=44);

• Non-small cell lung cancer - 60 mg/m2 CA4P in combination with bevacizumab and with paclitaxel and carboplatin q3wk (n=31).

CA4P was generally well tolerated in these studies, and toxicity did not appear to be significantly related to dose frequency. The Company believes that the combination of CA4P together with checkpoint inhibitors, such as pembrolizumab, could be synergistic. Mechanistically, the trial is also designed to assess the impact of CA4P on tumoral TGF-ß signature which would allow us to integrate CA4P into our TGF-ß platform as combination with checkpoint inhibitors, CAR-T, and vaccine/oncolytic viruses.

“This is the first of a series of planned clinical trials in melanoma patients to ultimately obtain marketing approval for CA4P in a Rare Pediatric Disease. The US FDA has previously granted the Company a Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients.” noted Dr. Vuong Trieu, Chairman and Chief Executive Office of Oncotelic.

About Oncotelic Therapeutics

Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.

Oncotelic is an artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-ß immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-ß RNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19 with data cleaning and datalock ongoing. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company also acquired PointR Data Inc. in November 2019.

For more information, please visit www.oncotelic.com

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